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Weekly GCP Challenge

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Challenge: ICH GCP General Questions III

Question Number 1:

According to ICH GCP where would you expect to find a section entitled

"Summary of Data and Guidance for the Investigator"
A
 Protocol
B
 Clinical Study Report
C
 Investigator Brochure
D
 Investigator Agreement

Question Number 2:

According to ICH GCP the "Selection and Withdrawal of Subjects" section of a protocol should include information about Subject Withdrawal criteria and procedures for which of the following:

  1. When and how to withdraw subjects from the trial
  2. The type and timing of data to be collected for withdrawn subjects
  3. Whether and how subjects are to be replaced
  4. The follow-up for subjects withdrawn from investigational product treatment/trial treatment
A
 1 and 2 only
B
 1, 2 and 3 only
C
 3 and 4 only
D
 All of them

Question Number 3:

According to ICH GCP the sponsor is responsible for securing agreement from all involved parties to ensure direct access to all trial related sites, source data/documents, and reports for what/who?

  1. the purpose of monitoring
  2. auditing by the sponsor
  3. inspection by domestic regulatory authorities
  4. inspection by foreign regulatory authorities
A
 3 and 4 only
B
 1 and 2 only
C
 2, 3 and 4 only
D
 All of them

Question Number 4:

According to ICH GCP section 5.15.2 "Record Access" the sponsor should verify that each subject has consented, in writing, to direct access to his/her original medical records for which of the following:

  1. Trial related monitoring
  2. Audit
  3. Regulatory Inspection
  4. IRB/IEC Review
A
 1 and 2 only
B
 2 and 3 only
C
 1, 2 and 3 only
D
 All of them

Question Number 5:

What does ICH GCP section 5.18.3 "Extent and Nature of Monitoring" state about the method of statistically controlled sampling?

 
A
 may be an acceptable method for selecting the data to be verified
B
 is an acceptable method for selecting the data to be verified
C
 is an acceptable method for selecting the subjects to be monitored
D
 may be an acceptable method for selecting the number of subjects to be monitored

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